PROAIR 3000 COMPRESSION SYSTEM

K993758 · Medical Compression Systems (Dbn) , Ltd. · JOW · May 19, 2000 · Cardiovascular

Device Facts

• Record ID: K993758
• Device Name: PROAIR 3000 COMPRESSION SYSTEM
• Applicant: Medical Compression Systems (Dbn) , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: May 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as: - prevention of deep vein thrombosis (DVT) . - enhancement of blood circulation - reduction of post-operative pain and swelling . - reduction of wound-healing time - stasis dermatitis . - treatment and assist healing of cutaneous ulceration . - venous stasis ulcers . - leg ulcers - chronic venous insufficiencies . - reduction of edema

Device Story

ProAir 3000 is a prescriptive, portable pneumatic compression system for lower limbs. Components include a control unit, calf/foot cuffs, connecting tubes, and electrical transformer. Device applies sequential compression via solenoid-controlled inflation cycles; operates in calf, foot, or combined modes. Used by patients and clinicians in clinical or home settings. Software-based protection monitors pressure via sensors; mechanical valve provides over-pressure relief. Output is controlled pneumatic compression to limbs. Benefits include improved circulation, DVT prevention, and accelerated wound healing.

Clinical Evidence

Comparative study performed to demonstrate safety and performance equivalence to predicate devices. No specific clinical trial data or statistical metrics (e.g., p-values, CIs) provided in the summary.

Technological Characteristics

Pneumatic compression system; portable control unit with solenoid valves and pressure sensors. Complies with IEC 60601-1, IEC 60601-1-2, EN-1441, and Mil-Std-810E. Includes mechanical over-pressure relief valve. Software-based pressure monitoring.

Indications for Use

Indicated for patients requiring controlled compression of the calf and/or foot for DVT prevention, circulation enhancement, pain/swelling reduction, wound healing, and treatment of venous stasis/ulcers, stasis dermatitis, and edema. Contraindicated in patients with gangrene, recent skin grafts, severe arteriosclerosis/ischemic vascular disease, congestive cardiac failure, massive/pulmonary edema, existing DVT, acute thrombophlebitis, acute infections, or pulmonary embolism.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Kendall Model 6325 SCD Sequel Compression System (K942664)
• Talley TM300 Sequential Multicom Compression System (K915092)
• Jobst Extremity Pump System 7500 (K921562)
• Cowboy XV [PlexiPulse®] (K981311)

Submission Summary (Full Text)

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K993758

# MAY 1 9 2000

## 510(K) SUMMARY

# ProAir 3000 Compression System

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

# Applicant's Name:

Medical Compression Systems (DBN) Ltd. 9 Harugei Malhut st. Tel-Aviv 69714, Israel Tel.: [phone] Fax: [phone]

### Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone]

# Date Prepared:

October, 1999

### Trade Name:

ProAir 3000 Compression System

# Classification Name:

Compressible Limb Sleeve

# Classification:

The FDA has classified compressible limb sleeves as class II devices (product code JOW, Regulation No. 870.5800) and they are reviewed by the Cardiovascular Panel.

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# Predicate Device:

- · Kendall Model 6325 SCD Sequel Compression System (Kendall Co.), cleared under K942664
- · Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915092
- · Jobst Extremity Pump System 7500 (Jobst Institute, Inc.) cleared under K921562
- · Cowboy XV [PlexiPulse®] (KCI New Technologies, Inc.) cleared under K981311

## Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the ProAir 3000 complies with the following voluntary standards: IEC 60601-1 (and amendments), IEC 60601-1-2. EN-1441, and applicable parts of Mil-Std-810E.

## Indications:

The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.

The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:

- prevention of deep vein thrombosis (DVT) .
- . enhancement of blood circulation
- reduction of post-operative pain and swelling .
- . reduction of wound-healing time
- stasis dermatitis .
- treatment and assist healing of cutaneous ulceration .
- venous stasis ulcers .
- . leg ulcers
- chronic venous insufficiencies .
- . reduction of edema

## Contraindications:

The ProAir 3000 compression system should not be used in the following cases: Gangrene, recent skin graft, severe arteriosclerosis or other ischemic vascular disease, congestive cardiac failure, massive edema, pulmonary edema, existing DVT, acute thrombophlebitis, acute infections, and during episodes of pulmonary embolism.

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#### Device Description:

The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components:

- Portable pneumatic control unit ●
- Pair of cuffs (calf and/or foot-ware) ●
- Pneumatic connecting tubes. .
- . Electrical transformer

During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.

## Substantial Equivalence:

Based on a series of safety and performance testing including a comparative study, Medical Compression Systems (DBN) Ltd. believes that the ProAir 3000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2000

Ms. Shoshana Friedman Medical Compression Systems Ltd. C/O Push-med Ltd. 117 Ahuza Street Ra'ananna 43373 Israel

Re: K993758 ProAir 3000 Compression System Requlatory Class: II Product Code: JOW Dated: March 5, 2000 Received: March 7, 2000

Dear Ms. Friedman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the bubbancearly of analy marketed predicate devices marketed in interstate encrobare) 80 rogal the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Shoshana Friedman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Brim E. Haneym
James E. Dillard III
Director
Division of Cardiovascular and

Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

# 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

ProAir 3000 Compression System Device Name:

#### Indications for Use:

The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.

The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:

- prevention of deep vein thrombosis (DVT) .
- enhancement of blood circulation .
- reduction of post-operative pain and swelling .
- reduction of wound-healing time .
- stasis dermatitis .
- treatment and assist healing of cutaneous ulceration .
- venous stasis ulcers .
- leg ulcers .
- . chronic venous insufficiencies
- reduction of edema .

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

M. Loree K. Buxerle